MANUF PACOP WITH ANSWER

1. A container which holds the drug and is in direct contact with the preparation is: Primary
container
2. Sterilization process for heat sensitive parenterals is by: Membrane filtration
3. Quarantined materials delivered in the warehouse are: Subject to test and assays
4. Caps used to hold rubber closure in place for vials are made of: Aluminium
5. Plastic material used ophthalmic solutions as package and applicator is: Polyethylene
6. Colorants are added to formulation for: Aesthetic purpose
7. Gas used to sterilize plastic materials is: Ethylene oxide
8. Control records required in the manufacture of drugs: Master formula
9. OTC labels of products indicate in front of the: Pharmacologic category
10. Certified colorants used for drugs and cosmetics but not food is: D&C dyes
11. The non-proprietary name of a drug product also refers to: Official name
12. Strength of a product is expressed in terms of: Potency
13. To control raw materials and finished products in the warehouse, the practice of: First in-first
out
14. To determine whether the product has undergone stability studies, the label indicates the:
Expiry date
15. The Inspection and Checking section of Quality Control is responsible for: Sampling of raw
materials delivered by suppliers
16. The bar marks found in labels of products serve to: Distinguish one product from the other
17. In labelling of a product, an unlabelled portion is provided for: Viewing the contents
18. Room temperature recognized by USP/NF is: 25 °C
19. The dispensing division of the warehouse requires a: Licensed pharmacist
20. To protect the contents of a bottle from the action of light id to use: Amber colored glass
21. Advantage of plastic containers over glass is: Lightness in weight
22. Products which have been bottled or stripped-packed but not yer labelled or packed into boxes
or barbons are termed: In-process
23. A batch or any portion of a batch of drug produced by a continuous process is: Lot
24. It refers to the release or movement of the components of the plastic container into the
contents; Leaching
25. Any substance of a drug, which is intended to furnish pharmacological activity or other effect in
the diagnosis, cure, mitigation, treatment or prevention of a disease or to affect any structure of
function of the body; Active ingredient
26. It refers to any distinctive combination of letters and/or numbers or both, by which the
complete history of the manufacture, control, packaging and distribution of a batch or lot of
drug is determined; Lot number
27. Type III glass is referred to as; Soda lime glass
28. An aerosol container material, which is lightweight and seamless. And is mostly used for
inhalation and topical aerosols; Plastic
29. A system for ensuring that products are consistently produced and controlled according to
quality standards. It is designed to minimize the risks of errors involved in any pharmaceutical
production, which cannot be eliminated through the final testing of the products; Current Good
Manufacturing Practice
30. A glass type, which is treated with sulphur dioxide and is suitable for buffered parenteral
solutions, has a pH of below 7, and is not reactive with glass; Type 2
31. The USP states that this adjuvant must be added to parenteral preparation contained in
multiple dose containers; Antimicrobial agents
32. High resistant borosilicate glass is also referred to as; Type I
33. An instrument used to check the tightness of the caps/closure; Torque tester